The US Food and Drug Administration (FDA) announces that Vivimed Life Sciences Pvt Ltd (Vivimed) is recalling 19 lots of Losartan Potassium Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. Due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out.
This product is made by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage). To date, neither Vivimed nor Heritage has received any reports of adverse events related to this recall.
Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, nephropathy in Type 2 diabetic patients and is packaged in 90-count and 1000-count bottles. The lots were manufactured by Vivimed at its Plant in Alathur, Chennai, India and Distributed by Heritage Pharmaceuticals Inc, East Brunswick NJ (Heritage) .
The affected Losartan Potassium tablets, includes the 19 lot numbers which are listed below:
- Losartan Potassium Tablets USP 25 mg: Lot number: CLO17006A; Expiry: 11/2019
- Losartan Potassium Tablets USP 50 mg: Lot number: CLO17007A; Expiry: 11/2019
- Losartan Potassium Tablets USP 50 mg: Lot number: CLO17008A; Expiry: 11/2019
- Losartan Potassium Tablets USP 50 mg: Lot number: CLO17009A; Expiry: 11/2019
- Losartan Potassium Tablets USP 50 mg: Lot number: CLO17009B; Expiry: 11/2019
- Losartan Potassium Tablets USP 50 mg: Lot number: CLO17010A; Expiry: 11/2019
- Losartan Potassium Tablets USP 100 mg: Lot number: CLO17012A; Expiry: 11/2019
- Losartan Potassium Tablets USP 100 mg: Lot number: CLO17013A; Expiry: 11/2019
- Losartan Potassium Tablets USP 100 mg: Lot number: CLO17014A; Expiry: 12/2019
- Losartan Potassium Tablets USP 100 mg: Lot number: CLO17015A; Expiry: 1/2020
- Losartan Potassium Tablets USP 100 mg: Lot number: CLO17016A; Expiry: 1/2020
- Losartan Potassium Tablets USP 100 mg: Lot number: CLO17017A; Expiry: 1/2020
- Losartan Potassium Tablets USP 100 mg: Lot number: CLO18001A; Expiry: 1/2020
- Losartan Potassium Tablets USP 100 mg: Lot number: CLO18002A; Expiry: 1/2020
- Losartan Potassium Tablets USP 100 mg: Lot number: CLO18002B; Expiry: 1/2020
- Losartan Potassium Tablets USP 100 mg: Lot number: CLO18020A; Expiry: 4/2020
- Losartan Potassium Tablets USP 100 mg: Lot number: CLO18021A; Expiry: 4/2020
- Losartan Potassium Tablets USP 100 mg: Lot number: CLO18022A; Expiry: 4/2020
- Losartan Potassium Tablets USP 50 mg: Lot number: CLO18023A; Expiry: 4/2020
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vivimed-life-sciences-pvt-ltd-issues-voluntary-nationwide-recall-losartan-potassium-25-mg-50-mg-and
In Hong Kong, the above products are not registered pharmaceutical products.
Currently in Hong Kong, there are 246 registered pharmaceutical products containing valsartan (83 products), candesartan (19 products), irbesartan (62 products), losartan (65 products) and olmesartan (17 products). All products are prescription-only medicines.
Regarding impurities in sartan-containing products, a public announcement was first issued on 6 Jul 2018, and letters to inform local healthcare professionals were issued by the Department of Health (DH) on 6 Jul 2018, 9 Jul 2018, 25 Jul 2018 and 3 Aug 2018. Related news was also previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 6 Jul 2018, with the latest update posted on 29 Apr 2019.
Regarding the announcements issued by various overseas drug regulatory authorities on the detection of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in sartan-containing products, the following 5 valsartan products and 1 irbesartan product were affected and recalled from the Hong Kong market on 6 Jul 2018 and 20 Dec 2018 respectively: HK-61786, HK-61787, HK-61784, HK-61785, HK-60794 and HK-63378. The DH noted that these recalls were completed.
The DH had collected samples of sartan-containing products in the local market for analysis. No NDMA and NDEA were detected.
Regarding the announcements issued by various overseas drug regulatory authorities on the detection of N-nitroso-N-methyl-4-aminobutyric acid (NMBA) in losartan, the DH endorsed the recall of 4 losartan products (HK-61932, HK-61933, HK-62634 and HK-62635) from the local market as a precautionary measure due to the potential for NMBA in the products on 11 Mar 2019. The DH noted that the recall was completed.
So far, the DH has received 17 cases of adverse drug reaction related to valsartan, candesartan, irbesartan, losartan and olmesartan. None of them is concluded to be related to the presence of impurities such as NDMA, NDEA and/or NMBA. The DH will keep vigilant on any safety updates on detection of impurities in sartan-containing products issued by overseas regulatory authorities.
Patients who are taking sartan-containing products should not stop taking the medicines, but should seek advice from their healthcare professionals as soon as possible for proper arrangement.
Ends/ Saturday, May 4, 2019
Issued at HKT 12:00
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